Active ingredient
Dobutamine
15 finished FDA listings contain Dobutamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DOBUTAMINE HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous
- Manufacturers / labelers
- 6
- Strengths listed
- 100 mg/100ml · 12.5 mg/ml · 200 mg/100ml · 250 mg/20ml · 400 mg/100ml
- Brand names in FDA listings
- Dobutamine Hydrochloride In Dextrose
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3616
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020201 | HOSPIRA | 1993-09-27 | 6 |
| NDA 020255 | BAXTER HLTHCARE | 1993-09-27 | 4 |
| ANDA 074086 | HOSPIRA | 1993-11-29 | 3 |
| ANDA 074277 | HIKMA | 1994-10-31 | 1 |
| ANDA 216131 | HAINAN POLY | 2022-12-21 | 1 |
Official labeling on DailyMed
- DOBUTAMINE IN DEXTROSE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 1 · 2026-07-03
- DOBUTAMINE IN DEXTROSE INJECTION, SOLUTION [HOSPIRA, INC.] · version 28 · 2026-06-05
- DOBUTAMINE IN DEXTROSE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 1 · 2026-06-01
- DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 19 · 2026-05-28
- DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION] · version 23 · 2026-02-26
- DOBUTAMINE INJECTION [SLATE RUN PHARMACEUTICALS] · version 4 · 2026-01-28
- DOBUTAMINE IN DEXTROSE INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST] · version 2 · 2026-01-08
- DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 11 · 2024-12-10
- DOBUTAMINE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 6 · 2024-07-11
- DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 6 · 2024-02-20
- DOBUTAMINE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 3 · 2024-02-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.